M Mason Macenski, Ph.D.

M Mason Macenski, Ph.D. Email and Phone Number

Vice President Clinical and Regulatory Affairs at Miromatrix @
M Mason Macenski, Ph.D.'s Location
Minneapolis, Minnesota, United States, United States
M Mason Macenski, Ph.D.'s Contact Details

M Mason Macenski, Ph.D. work email

M Mason Macenski, Ph.D. personal email

n/a
About M Mason Macenski, Ph.D.

Dr. Macenski has almost 30 years of biomedical research and management experience spanning both academia and the medical device industry. He began his career as a psychiatry faculty member at the University of Texas Medical School examining central nervous system drug effects on behavior. After a successful 10-year academic run, Dr. Macenski refocused on clinical research and medical devices. Over the last 15 years he has held various management positions in the medical device industry including Clinical Hip Operations Manager, Scientific Affairs Manager for biologic research and executive leadership positions as Global Director of Clinical Affairs at Zimmer Spine and Head of Clinical Affairs at Miromatrix. He possesses substantial experience in experimental design and clinical trial management as well as a thorough understanding of regulatory environments including FDA and ISO. He has successfully recruited, managed and developed talent and has managed off-site locations in the US and EU. Dr. Macenski was awarded a Ph.D. in behavioral pharmacology from the University of Minnesota. His scholarship is evidenced by authorship of numerous peer-reviewed scientific articles across multiple diverse fields including CNS drug action, human drug abuse, behavioral economics, spine pathology, autologous proteins, and osteoarthritis. He has over 50 conference presentations and is currently an associate editor for The Spine Journal.

M Mason Macenski, Ph.D.'s Current Company Details
Miromatrix

Miromatrix

Vice President Clinical and Regulatory Affairs at Miromatrix
M Mason Macenski, Ph.D. Work Experience Details
  • Miromatrix
    Vice President Clinical And Regulatory Affairs
    Miromatrix Jun 2021 - Present
    Dr. Macenski is the Vice President of Clinical and Regulatory Affairs at Miromatrix. He is a member the senior leadership team and is responsible for clinical and regulatory strategy and operations for Miromatrix. This includes regulatory strategy and submissions for Miromatrix’ whole organ program including the primary FDA liaison. He also has responsibility for first-in-human clinical trails for both the bioengineered human liver and bioengineered human kidneys transplant programs.
  • Miromatrix
    Head Of Regulatory & Clinical Affairs
    Miromatrix Jan 2017 - Jun 2021
    Dr. Macenski is the head of regulatory and clinical operations for Miromatrix. He is responsible for regulatory strategy and submissions and moving to first-in-human clinical trials for Miromatrix’ whole organ program including the bioengineered human liver and bioengineered human kidney transplant programs.
  • Zimmer Biomet
    Clinical Hip Operations Lead, Americas
    Zimmer Biomet Jan 2015 - Jan 2017
    Warsaw, Indiana, Us
    Responsible for the clinical hip research team and all clinical hip research in the Americas including IDEs and required post-market surveillance plan studies. Oversight and hands on for all clinical operations.
  • Zimmer Biomet Biologics
    Scientific Affairs Manager
    Zimmer Biomet Biologics Nov 2013 - Jan 2015
    Warsaw, Indiana, Us
    Responsible for global clinical and regulatory strategy for nSTRIDE APS, platelet rich plasma platform. Oversight of European phase I, II, and III clinical trials and US IDE. Completed protocol development and US regulatory submission. Oversight and hands on for all clinical operations.
  • Masonovations
    Principal
    Masonovations Apr 2011 - Nov 2013
    Clinical consulting for medical devices. Included protocol production, enrollment enhancement strategies, KOL relations, advisory board set-up and coordination, regulatory pathways, publication planning and scientific writing. Clients included: Ceterix, Trans1, Baxano, Biomet.
  • Zimmer Spine
    Global Director Clinical Affairs
    Zimmer Spine Oct 1999 - Mar 2011
    Warsaw, Indiana, Us
    As a member of the Executive Staff, Dr. Macenski, had responsibility for Zimmer's world-wide clinical spine research effort. He managed all global clinical research operations with reports at multiple domestic and international locations; Had responsibility for strategic, regulatory and budgetary aspects of all human research; Developed publication, research and reimbursement strategy with Brand Management, Product Development and Health Economics; Completed M&A due diligence and assessed emergent technologies from clinical perspective; Participated in acquisition activities; Developed and implemented global research database, crossfunctional strategic alignment dashboard, project management and research tracking metrics.• Associate Editor for The Spine Journal• Clinical Affairs team lead in 360 million merger and acquisition• Coordinated all aspects of PMA preparation and presentation to an FDA advisory panel• Coordinated all aspects of clinical data based regulatory submissions to: Comisiόn Federal para la Protecciόn contra Riesgos Sanitarios National Institute for Health and Clinical Excellence Bundesamt für Gesundheit
  • University Of Texas Medical School
    Associate Professor Psychiatry
    University Of Texas Medical School Jan 1991 - Jun 1999
    Responsible for all aspects of a pre-clinical drug self-administration laboratory. Managed scientific personnel through M.D. and Ph.D. level. Coordinated multiple federally funded projects. Developed budgets and acquired federal research funds. Interpreted data and disseminated information both orally and written.Authored multiple scientific manuscripts and research articles which were published in numerous peer reviewed journals.Invited lecturer at Yale Neuroscience Institute

M Mason Macenski, Ph.D. Skills

Medical Devices Fda Spine Clinical Trials Clinical Research Orthopedic Regulatory Submissions Operating Room Orthopedics Regulatory Affairs Surgery Neurosurgery Clinical Development Strategy Surgeons Product Launch Disposables Cross Functional Team Leadership Interventional Cardiology Capa

M Mason Macenski, Ph.D. Education Details

  • University Of Minnesota
    University Of Minnesota
    Behavioral Pharmacology
  • Purdue University Northwest
    Purdue University Northwest
    Psychology

Frequently Asked Questions about M Mason Macenski, Ph.D.

What company does M Mason Macenski, Ph.D. work for?

M Mason Macenski, Ph.D. works for Miromatrix

What is M Mason Macenski, Ph.D.'s role at the current company?

M Mason Macenski, Ph.D.'s current role is Vice President Clinical and Regulatory Affairs at Miromatrix.

What is M Mason Macenski, Ph.D.'s email address?

M Mason Macenski, Ph.D.'s email address is ma****@****ast.net

What schools did M Mason Macenski, Ph.D. attend?

M Mason Macenski, Ph.D. attended University Of Minnesota, Purdue University Northwest.

What skills is M Mason Macenski, Ph.D. known for?

M Mason Macenski, Ph.D. has skills like Medical Devices, Fda, Spine, Clinical Trials, Clinical Research, Orthopedic, Regulatory Submissions, Operating Room, Orthopedics, Regulatory Affairs, Surgery, Neurosurgery.

Free Chrome Extension

Find emails, phones & company data instantly

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

Download 750 million emails and 100 million phone numbers

Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.